Urothelium Transitional Cell Carcinoma Clinical Trial
Official title:
A Randomised Phase II/III Study of Cabazitaxel Versus Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium
Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III setting.
Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the
informed consent, they will be randomised to receive treatment based on cabazitaxel or
vinflunine according to the following study schema:
(Randomize 1:1)
- Cabazitaxel 25 mg/m2 q3w
- Vinflunine 250-320 mg/m2 q3w
Random assignment of treatment will be stratified by the presence of 0 versus 1 of the
following unfavourable prognostic risk factors proposed recently by Bellmunt et al. (1):
- Eastern Cooperative Oncology Group (ECOG) PS 1.
- Anaemia with Hb <10 g/dL.
- Presence of liver metastases.
All patients enrolled in the study will receive a cycle of treatment with the study
medication (cabazitaxel or vinflunine) every 21 days until disease progression or
intolerable/unacceptable toxicity. Tumour evaluations will be scheduled every 6 weeks until
progression
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment